Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel

PHASE1TerminatedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

May 9, 2014

Primary Completion Date

April 28, 2017

Study Completion Date

October 2, 2017

Conditions
Medical Oncology
Interventions
DRUG

BAY1161909

Given orally, with a starting dose of 0.75 mg twice daily from C1D1 onwards in a 2 days on/5 days off dosing schedule as single agent treatment in Cycle 1 (14 days), and from C2D8 onwards in a 2 days on/5 days off dosing schedule in 28-day cycles. For single-dose PK cohort: a single oral dose on C1D1

DRUG

Paclitaxel

75 mg/m\^2 (initial dose escalation) or 90 mg/m\^2 (second dose escalation), weekly intravenously (IV) infusion on D1, D8, and D15 of the 28-day cycles from C2D1

Trial Locations (6)

37203

Nashville

48201

Detroit

78229

San Antonio

90403

Santa Monica

06510

New Haven

02215

Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY